Global pharma giant AstraZeneca’s triple-combination inhaler Breztri Aerosphere has secured US approval for a major new use: the maintenance treatment of asthma in adults and children aged 12 and older.

 

The decision by the US Food and Drug Administration (FDA) expands the reach of a therapy already widely used in respiratory care. Breztri combines budesonide, glycopyrrolate and formoterol fumarate into a single inhaler, pairing an inhaled corticosteroid and long-acting beta2-agonist with a long-acting muscarinic antagonist. 

 

The aim is to simplify and strengthen long-term control of airway disease through triple therapy in one device.

 

Originally approved in 2020 at a lower dose for chronic obstructive pulmonary disease (COPD), Breztri has since become a global mainstay, prescribed to more than 6.8 million patients in 2025.

 

The asthma approval is backed by Phase III KALOS and LOGOS trials, which evaluated the drug in a broad population of patients with asthma, including those with and without recent exacerbations. 

 

The results showed Breztri delivered “a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled ICS/LABA.” The trials also found a rapid response: “a significant improvement from baseline in lung function within five minutes after the first dose.”

 

The therapy is strictly for long-term control and not for sudden symptom relief. It will not replace a rescue inhaler.

 

Njira Lugogo, Clinical Professor, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, said: “Despite the availability of dual maintenance therapy, many patients are still at risk for exacerbations and experience daily breathing difficulties, reduced lung function and the ongoing fear of worsening symptoms. 

 

"The FDA approval of Breztri as the only maintenance triple therapy for people with asthma 12 years of age and older marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner.”

 

From AstraZeneca, Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: “As the fastest growing fixed-dose triple-combination therapy in COPD, Breztri is already improving outcomes for people suffering with COPD, and we are proud to extend its benefits to asthma patients. 

 

"The FDA’s approval of Breztri in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases.”